Amino acid L-isoleucine synthesized through fermentation using Escherichia coli strain CCTCC M 20231916
The European Union (EU) has endorsed the authorization of a new feed additive containing L-isoleucine, a crucial amino acid, under the category of nutritional additives. This sought-after authorization, according to Annex I of Regulation (EC) No 1831/2003, is intended for use in all animal species.
The feed additive, which contains L-isoleucine as an active substance with a minimum purity of 90% (w/w, based on dry matter), is designed to be added directly to compound feed or through premixtures (or complementary feed) and water. The Applicant did not propose a minimum or maximum L-isoleucine content in compound feed or water.
The EU method (or equivalent EN ISO 13903 method) is considered applicable for the determination of isoleucine in the feed additive, premixtures compound feed, and water by the European Reference Laboratory for Feed Additives (EURL). The EURL also recommends the Food Chemical Codex (FCC) "L-isoleucine monograph" for the identification of L-isoleucine in the feed additive.
For the determination of isoleucine in the feed additive and premixtures, the EURL considers the EN ISO 17180 method suitable. This method, based on ion-exchange chromatography (IEC) with optical (visible - VIS or fluorescence - FLD) detection, has been proposed by the Applicant.
In addition, the Applicant has proposed the ring-trial validated European Union (EU) method (Commission Regulation (EC) No 152/2009) based on IEC-VIS for the determination of isoleucine in compound feed and water. The EURL acknowledges this method's applicability for the current product.
The EURL, through its regulatory framework for feed additives, has recommended the official control of the identification and determination of L-Isoleucine in feed additives using EU methods based on ion exchange chromatography combined with optical detection. Further testing or validation of the methods is not considered necessary according to the EURL.
An authorization is sought under Article 4 for L-isoleucine produced by fermentation with Escherichia coli CCTCC M 20231916. The approval of this feed additive is expected to contribute significantly to the nutritional requirements of various animal species, enhancing their overall health and productivity.
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